Method of creating an accurate bone and soft-tissue digital dental model

ABSTRACT

A method of creating a 3-D anatomic digital model for determining a desired location for placing at least one dental implant in a patient&#39;s mouth. The method comprises the act of obtaining a first dataset associated with hard tissue of the patient&#39;s mouth. The method further comprises the act of obtaining a second dataset associated with soft tissue of the patient&#39;s mouth. The method further comprises the act of combining the first dataset and the second dataset to create a detailed structure of hard tissue and soft tissue having variable dimensions over the hard tissue.

FIELD OF INVENTION

The present invention relates generally to dental implant systems. Moreparticularly, the present invention relates to methods for creating andusing accurate bone and soft-tissue digital dental models, surgicalplans, and surgical guides.

BACKGROUND OF THE INVENTION

The dental restoration of a partially or wholly edentulous patient withartificial dentition is typically done in two stages. In the firststage, an incision is made through the gingiva to expose the underlyingbone. After a series of drill bits creates an osteotomy in the bone, adental implant is placed in the jawbone for osseointegration. The dentalimplant generally includes a threaded bore to receive a retaining screwholding mating components therein. During the first stage, the gumtissue overlying the implant is sutured and heals as theosseointegration process continues.

Once the osseointegration process is complete, the second stage isinitiated. Here, the gum tissue is re-opened to expose the end of thedental implant. A healing component or healing abutment is fastened tothe exposed end of the dental implant to allow the gum tissue to healtherearound. Preferably, the gum tissue heals such that the aperturethat remains generally approximates the size and contour of the aperturethat existed around the natural tooth that is being replaced. Toaccomplish this, the healing abutment attached to the exposed end of thedental implant has the same general contour as the gingival portion ofthe natural tooth being replaced.

During the typical second stage of dental restoration, the healingabutment is removed and an impression coping is fitted onto the exposedend of the implant. This allows an impression of the specific region ofthe patient's mouth to be taken so that an artificial tooth isaccurately constructed. After these processes, a dental laboratorycreates a prosthesis to be permanently secured to the dental implantfrom the impression that was made.

In addition to the more traditional system for placing dental implantsdescribed above, some systems use guided placement of the dentalimplants. To do so, a surgical guide is placed in the patient's mouth ata known location. The surgical guide includes openings for providing theexact placement of drill bits used to create the osteotomy. Once theosteotomy is completed, the surgical guide may permit the dental implantto be placed through the same opening and enter the osteotomy that wasguided by the surgical guide.

Surgical guides are typically created based on a dental scan (e.g.,using a computed tomography (“CT”) scanner) of the patient's mouth. A CTscanner provides the details of the patient's bone tissue, jawbone, andremaining teeth so that the surgical guide may be developed based oncomputer-aided design (“CAD”) and computer-aided manufacturing (“CAM”).One example of the use of a CT scanner is disclosed in U.S. PatentPublication No. 2006/0093988 to Swaelens et al. (“Swaelens”), which isherein incorporated by reference in its entirety. Swaelens alsodescribes the use of various tubes that may be placed within a surgicalguide to receive the drill bits and implants. One example of the use ofa CT-scan to develop a surgical plan involving a surgical guide isdisclosed in U.S. Patent Application Ser. No. 61/003,407, filed Nov. 16,2007, and described in Biomet 3i's Navigator™ system product literature,“Navigator™ System For CT Guided Surgery Manual” that is publiclyavailable, both of which arc commonly owned and herein incorporated byreference in their entireties. Another example of the use of a CT-scanto develop a surgical plan is disclosed in U.S. Patent Publication No.2006/0093988, which is herein incorporated by reference in its entirety.

CT scans tend to produce highly precise data for hard tissue (such asbone tissue or teeth) but produce less precise data for soft tissue(such as the gingival tissue). Thus, existing 3-D anatomic digitalmodels and surgical guides typically do not accurately account for thegingival tissue overlying the patient's jawbone. Other techniques foracquiring gingival tissue data, such as using a barium sulfate-infusedscanning appliance, are time and/or labor intensive and are often notparticularly accurate.

Other methods are typically used to produce accurate soft tissue data.For example, soft tissue data may be acquired by taking an impression ofthe inside of a patient's mouth, using an intra-oral scanner, or thelike. These methods, however, fail to provide accurate data relating tothe hard tissue of the patient's mouth and, therefore, cannot beleveraged to improve the quality of the 3-D anatomic digital models andsubsequent surgical guides created using these models.

When considering the dental and/or surgical plan for a specific patient,the maximum depth of the distal end of the dental implant within thebone is important so that the sinus cavity and mandibular canal may beavoided. Additionally, the location of the implant(s) relative to thegingival surface and underlying bone is important, especially one thatinvolves the placement of several dental implants. Thus, it is importantthat precise data relating to both the hard tissue (e.g., bone structureand teeth) and the soft tissue (e.g., gingival tissue) of the patient'smouth is obtained and used to create a 3-D anatomic digital model fromwhich the surgical guide may be developed.

Thus, there exists a need to develop an improved method for creating ahighly accurate digital model that incorporates accurate data relatingto both the hard tissue and the soft tissue of the patient's mouth andthat forms an accurate basis from which to create a surgical model, asubsequent surgical guide, and/or custom abutments.

SUMMARY OF THE INVENTION

According to one process of the present invention, a method of creatinga 3-D anatomic digital model for determining a desired location forplacing at least one dental implant in a patient's mouth is disclosed.The method comprises the act of obtaining a first dataset associatedwith hard tissue of the patient's mouth. The method further comprisesthe act of obtaining a second dataset associated with soft tissue of thepatient's mouth. The method further comprises the act of combining thefirst dataset and the second dataset to create a detailed structure ofhard tissue and soft tissue having variable dimensions over the hardtissue.

According to another process of the present invention, a method fordeveloping a surgical guide for guiding the insertion of at least onedental implant into a desired location in a patient's mouth isdisclosed. The method comprises the act of obtaining a first datasetassociated with hard tissue of the patient's mouth and a second datasetassociated with soft tissue of the patient's mouth. The method furthercomprises the act of forming a 3-D anatomic digital model including thefirst dataset and the second dataset. The method further comprises theact of creating a surgical plan defined by the 3-D anatomic digitalmodel. The surgical plan includes virtual implant positions. The methodfurther comprises the act of scanning a cast model of the patient'smouth to obtain a third dataset. The method further comprises the act ofcombining the third dataset with the 3-D anatomic digital model. Themethod further comprises the act of placing at least one implant analogin the cast material in a location replicating the location of the atleast one virtual implant in accord with the surgical plan. The methodfurther comprises the act of attaching at least one implant-analog mountand at least one master tube into the cast model in accordance with thesurgical plan to form a master cast. The method further comprises theact of pouring a flowable material over the master cast and around theat least one master tube. The method further comprises the act ofallowing the flowable material to harden. The hardened material formsthe surgical guide. The method further comprises the act of removing theat least one implant-analog mount and the surgical guide from the mastercast.

According to another process of the present invention, a method ofdeveloping a surgical guide for guiding the insertion of at least onedental implant into a desired location in a patient's mouth isdisclosed. The method comprises the act of scanning the inside of thepatient's mouth to obtain a first dataset associated with bone tissue,teeth, or a combination thereof. The method further comprises the act oftaking an impression of the patient's mouth. The method furthercomprises the act of scanning the impression to obtain a second datasetassociated with a gingival surface. The method further comprises the actof merging the first dataset with the second dataset to form a 3-Danatomic digital model having gingival thickness data. The methodfurther comprises the act of forming a cast model from the impression.The method further comprises the act of creating a surgical plan havingvirtual implants via the 3-D anatomic digital model, the virtualimplants having location information associated therewith. The methodfurther comprises the act of scanning the cast model to obtain a thirddataset. The method further comprises the act of, using a robot, placingat least one implant analog in the cast model at a position dictated bythe virtual implant location information.

According to another embodiment of the present invention, a method ofdeveloping a 3-D model of the patient's mouth is disclosed. The methodcomprises the act of scanning the inside of the patient's mouth toobtain a first dataset including data associated with the jawbone, bonetissue, teeth, or combinations thereof. The method further comprises theact of scanning the inside of the patient's mouth or an impression ofthe patient's mouth to obtain a second dataset including data associatedwith the gingival surface. The method further comprises the act ofmerging the first dataset with the second dataset to form a combineddataset. The method further comprises the act of removing overlappingdata from the combined dataset to form a modified dataset. The methodfurther comprises the act of adding soft tissue data associated with theregion between the gingival surface and the jawbone to the combineddataset.

According to another process of the present invention, a method ofplacing a dental implant and prosthesis in a patient's mouth isdisclosed. The method comprises the act of developing a 3-D anatomicdigital model based on hard tissue data obtained from a computedtomography scan of the patient's mouth and soft tissue data obtainedfrom an intra-oral scan or a dental impression of the patient's mouth.The method further comprises the act of developing a cast model of thepatient's mouth. The method further comprises the act of scanning thecast model to obtain cast data. The method further comprises the act ofmerging the 3-D anatomic digital model with the cast data to obtainmerged data. The method further comprises the act of developing a mastercast by installing a dental implant analog to replicate a desiredlocation of the dental implant into the cast model using the mergeddata. The method further comprises the act of developing on the mastercast a surgical guide to be used in the placement of the dental implantin the patient's mouth. The surgical guide includes at least one openinggenerally adjacent to the dental implant analog. The method furthercomprises the act of placing the surgical guide in the patient's mouth.The method further comprises the act of installing the dental implantthrough the at least one opening in the surgical guide. The methodfurther comprises the act of after installing the dental implant,removing the surgical guide from the patient's mouth. The method furthercomprises the act of attaching a dental prosthesis to the dentalimplant.

The above summary of the present invention is not intended to representeach embodiment or every aspect of the present invention. This is thepurpose of the figures and the detailed description which follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an implant, a master tube for use in a surgicalguide, and a guide tube for use with the master tube;

FIG. 1B schematically illustrates the various axially orienteddimensions of the components in FIG. 1A;

FIGS. 2A-2C are side, isometric, and top views of an implant mount foruse in driving an implant into the osteotomy in the patient's mouth;

FIG. 3 illustrates the implant mount of FIGS. 2A-2C attached to theimplant of FIGS. 1A-1B;

FIGS. 4A-4C are views of a master tube that may be placed in a surgicalguide;

FIGS. 5A-5B arc side and top views of an implant-analog mount that maybe used to develop the surgical guide;

FIG. 6 is a side view of the implant-analog mount in FIG. 5A-5B that isused with an implant analog;

FIG. 7A is a flow diagram detailing a method of forming a surgical planaccording to one process;

FIG. 7B is a 3D computer model (a virtual model) of a portion of apatient's mouth;

FIG. 8 is a flow diagram detailing a method of forming a master castusing the surgical plan of FIGS. 7A-7B according to one process;

FIG. 9 illustrates flowable cast material being poured into animpression of a patient's gingival surface to develop a cast model ofthe patient's mandible;

FIG. 10A illustrates a robot that may be used to modify the cast modelof FIG. 9;

FIG. 10B illustrates the robot of FIG. 10A as it creates an opening inthe cast model;

FIG. 10C illustrates the robot of FIG. 10A after it has created anopening in the cast model;

FIG. 10D illustrates the robot of FIG. 10A placing an implant analog inthe cast model;

FIG. 10E illustrates the details of the opening of the cast model afterthe robot of FIG. 10A has placed the implant analog therein;

FIG. 11 illustrates a master cast formed using the process of FIGS. 8and 10, according to one embodiment;

FIG. 12 is a flow diagram detailing a method of forming a surgical guideaccording to one process;

FIGS. 13A-13B illustrate the combination of the implant analogs andassociated mounts of FIG. 6 after being placed in the master cast ofFIG. 11;

FIG. 14 is a top view of a surgical guide that may be used in apatient's mouth to guide the placement of eight dental implants; and

FIG. 15 illustrates the surgical guide of FIG. 14 fixed in the patient'smouth.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and will herein be described in detail. Itshould be understood, however, that it is not intended to limit theinvention to the particular forms disclosed but, on the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the invention as defined by theappended claims.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The present invention is directed to methods for developing a single,highly accurate 3-D anatomic digital model that accurately accounts forboth hard tissue data and soft tissue data. Such a model is required forcomputer-based surgical planning and an accurate surgical guide.

FIGS. 1-4 illustrate examples of implants, implant mounts, master tubes,and drill bits that may be used with a surgical guide formed accordingto embodiments of the present invention. FIGS. 5-6 illustrate implantanalogs and implant-analog mounts that may be used to form the surgicalguide. These components are also described in U.S. Provisional PatentApplication Ser. No. 61/003,407, which is herein incorporated byreference in its entirety.

FIG. 1A illustrates some of the external components used for installinga dental implant 10 during dental surgery in a patient's mouth inaccordance with a predetermined surgical plan. FIG. 1B illustrates thedimensions, which are discussed in more detail below, that are used toensure the proper axial location of the dental implant 10 in thepatient's bone. As shown, the implant 10 includes a non-rotationalfeature 12 in the form of a hexagonal socket and a threaded bore 14located below the non-rotational feature 12. The non-rotational feature12 may also have other internal forms, such as a different polygonal ornon-round shape, and it may also be present in an external form, such asin a hexagonal (or other polygonal or non-round) boss that protrudesabove the top surface of the implant 10. The external components includea master tube 20 that will be located within a surgical guide, which isdiscussed in more detail below, and a guide tube 30 having an upper lip32. The guide tube 30 is like a bushing that fits snugly within themaster tube 30 such that the upper lip 32 rests on the upper surface ofthe master tube 20.

With reference to FIG. 1B, to properly locate the implant 10 in theaxial direction in accordance with the surgical plan, the lengthdimension “C” of the implant 10 must be known. Further, the dimension“A” is the distance from the seating surface of the implant 10 to thebottom of the master tube 20, which has a known length of dimension “D.”Dimension “B” is the thickness of the lip 32 of the guide tube 30, whichreceives drill bits for drilling the osteotomy. Dimension “E” is thelength dimension of an implant mount (e.g., implant mount 40 of FIGS.2A-2C) and implant-analog mount (e.g., implant-analog mount 100 of FIG.5A) that will be attached to the implant 10 and used to drive theimplant 10 into the bone in accordance with the surgical plan. Thesurgical guide discussed below will have an axial dimension directlyover each implant 10 that is greater than dimension “D” but less thandimension “E.” This axial dimension of the surgical guide over thedental implant 10 will be chosen to ensure that the distance “E” isequal to one of several known and standard lengths for the implant mount40 (e.g., 7.5 mm, 9 mm, 10.5 mm, 12 mm). In short, the dimensions “A,”“B,” “C,” “D,” and “E” of FIG. 1B are considered in developing thesurgical guide that will place each dental implant 10 in accordance withthe surgical plan.

FIGS. 2A, 2B, and 2C illustrate one length of the implant mount 40 thatmay be used with the dental implant 10. Implant mounts are generallyavailable in various lengths and diameters corresponding with variousimplant widths. The implant mount 40 includes a non-rotational feature42 (as shown, a hexagonal boss) at one end of a main body 44 for matingwith the non-rotational feature 12 of the implant 10. At the other endof the main body 44 is a flange 46 having a plurality of notches 47. Adriving element 48 is located above the flange 46 for receiving torquefrom a manual or power drive to rotate the attached implant 10 into thebone of the patient. The implant mount 40 further includes a bore thatreceives a screw 49 extending through the entire implant mount 40. Thebore may include internal threads 50 for capturing the threads of thescrew 49 such that the screw 49 and the implant mount 40 are heldtogether even when the implant mount 40 is unattached to a dentalimplant 10.

For visual alignment purposes, each notch 47 is aligned with one surfaceof the non-rotational feature 42 of the implant mount 40. In theillustrated embodiment, each notch 47 is also aligned with one surfaceof the driving element 48. Thus, the notches 47 help to identify theorientation of the underlying non-rotational feature 42. This isimportant because, once the implant 10 is installed in the patient'sbone, the non-rotational feature 12 of the implant 10 must be at a knownangular position in the patient's bone for a predefined prostheticcomponent (e.g., a bar, an abutment, etc.) to be aligned in the properangular orientation when its non-rotational feature mates with thenon-rotational feature 12 of the implant 10.

FIG. 3 illustrates the dental implant 10 attached to the implant mount40 via the screw 49. Additionally, the non-rotational feature 12 of theimplant 10 is coupled to the non-rotational feature 42 of the implantmount 40. Due to the position of the notches 47 on the flange 46, eachnotch 47 a is aligned with corresponding surfaces 12 a, 42 a of thenon-rotational features 12, 42. Accordingly, although a clinician cannotsee the non-rotational feature 12 of the implant 10, the clinician stillknows the angular orientation of the non-rotational feature 12 byinspecting the notches 47 on the implant mount 40.

FIGS. 4A-4C illustrate the details of the master tube 20 according toone embodiment. The master tube 20 includes a main body 82 with notches84 located on the upper surface 86. The master tube 20 includes aroughened side surface 88 that allows the master tube 20 to be betterattached to the material of the surgical guide (e.g., surgical guide 390of FIG. 14). As shown, the roughened surface 88 includes a spiral groovearound the circumference of the main body 82 and axial grooves along thecentral axis of the main body 82 that intersect the spiral grooves. Inother embodiments, the main body 82 may be a knurled surface or have anyother surface structure that assists in fixing the master tube 20 withinthe material of the surgical guide.

The master tube 20 may come in different sizes to accommodate dentalimplants having different diameters. For example, a master tube 20 withan internal diameter of 4.1 mm may be used for implants 10 havingdiameters of 4.0 mm or smaller. Additionally, a master tube 20 with aninternal diameter of 5.1 mm may be used for implants 10 having diametersbetween 4.0 mm and 5.0 mm.

According to one embodiment, a master tube may include a flange at theupper surface that allows the master tube to be axially retained in thesurgical guide with better precision. The undersurface of the flangeengages the material of the surgical guide, so as to resist any axialmovement of the master tube relative to the surgical guide. The flangemay rest on the top surface of the surgical guide or within acounterbored opening within the top surface of the surgical guide. Ineither case, the dimensions “A,” “B,” “C,” “D,” and “E” of FIG. 1B arealso applicable to the master tube so as to develop a surgical guidethat will place each dental implant 10 in accordance with the surgicalplan.

FIGS. 5A-5B illustrate an implant-analog mount 100, according to oneembodiment, that may be used to assist in developing the surgical guide.The implant-analog mount 100 includes a main body 102 and an expandabletop section 104, which includes a plurality of slots 106. The lower endof the main body 102 includes a non-rotational feature 108 (e.g., ahexagonal boss) that will engage a corresponding mating surface in theimplant analog. The implant-analog mount 100 includes a screw 109 with alarge rotatable head 110. When the rotatable head 110 is tightened suchthat the screw 109 is tightened into the implant analog, furtherrotation causes the tapered section 111 of the screw 109 to force theexpandable top section 104 outward.

An orientation pin 112 is located on the expandable top section 104 andis aligned with one of the flat surfaces on the non-rotational feature108. The orientation pin 112 extends below the top flange of theexpandable top section 104 and, as described below, mates with the notch84 within the master tube 20 when developing the master cast describedbelow.

FIG. 6 illustrates the implant-analog mount 100 attached to an implantanalog 120, which will also be used to assist in forming the surgicalguide. The implant analog 120 has an upper surface that replicates theupper surface of the dental implant 10. Thus, the implant analog 120includes a non-rotation feature 122 that mates with the non-rotationalfeature 108 of the implant-analog mount 100. When doing so, theorientation marker 112 is then aligned with the non-rotation feature 122of the implant analog 120. The implant analog 120 also includes internalthreads 124 for receiving the screw 109 to hold the implant analog 120to the implant-analog mount 100.

According to the embodiments of the present invention, a 3-D anatomicdigital model for a patient may be developed by merging (1) dataobtained by scanning the patient's mouth with a CT scanner (or othersuitable scanning technologies or devices) to obtain data associatedwith the bone structure, teeth, and/or pre-placed physical markers(e.g., in the case of a fully edentulous patient, described in moredetail below) with (2) data obtained by taking an impression of thepatient's mouth and scanning the impression or by scanning the inside ofthe patient's mouth with an intra-oral scanner to obtain data associatedwith the gingival surface. A surgical plan, created using this 3-Danatomic digital model in conjunction with planning software, is thenused to precisely place an implant analog(s) into a cast of thepatient's pre-surgical anatomic scenario in a position replicating adesired position of the dental implant to be inserted into the patient'smouth, thereby creating a master cast. The master cast is then used tocreate a surgical guide.

The remainder of the detailed description will assume that the patientis edentulous and that the surgical guide is resting on the soft tissue(e.g., the gingival surface). For fully edentulous patients, a hardtissue reference common to both the hard tissue dataset and the softtissue dataset is required for shape matching, as this hard tissuereference will be the only data common to both the hard tissue datasetand the soft tissue dataset. Thus, a physical marker may be placed inthe patient's mouth as a reference point. The marker may include a bonepin, a fixation screw, or the like. It should be understood, however,that the embodiments of the present invention may also be used withpartially edentulous patients.

Referring to FIG. 7A, a method of creating a surgical plan according toone process is illustrated. To create the surgical plan,three-dimensional (“3-D”) data relating to a patient's hard tissue isobtained using a dental scan such as a CT scan or other suitablescanning technologies or devices at step s150. Specifically, the CTscanner digitizes data relating to the patient's bone structure (e.g.,jawbone) and teeth to create a hard tissue dataset. The hard tissuedataset includes accurate hard tissue data.

At step s152, a 3-D soft tissue dataset is acquired. According to oneembodiment, an impression (e.g., impression 310 of FIG. 9) is taken ofthe patient's gingival surface and teeth (if any) using commontechniques involving the use of impression material within the patient'smouth. The impression is then scanned and digitized to obtain the softtissue dataset. Alternatively, a stone cast of the patient's mouth isformed, and the stone cast is scanned and digitized. One suitable typeof scanner is the 3D Scanner D-250™ manufactured by 3Shape A/S(Copenhagen, Denmark) (“3Shape Scanner”). In another embodiment, thesoft tissue dataset is obtained by scanning the inside of the patient'smouth using an intra-oral scanner.

The resulting soft tissue dataset obtained at step s152 includes veryaccurate data of the outer surface of a patient's dentition. The softtissue dataset is a digitized surface of zero thickness and representsthe outer surface of the teeth and gingival tissue. Although in theprocess of FIG. 7A, the soft tissue dataset is obtained after obtainingthe hard tissue dataset, it is also contemplated that the soft tissuedataset may be obtained prior to obtaining the hard tissue dataset.

At step s154, a shape-matching algorithm is applied to merge the hardtissue dataset and the soft tissue dataset. The shape-matching algorithmutilizes features common to both datasets, such as the outer surface ofthe dentition, pre-placed physical markers, existing teeth, or the like,to merge the two datasets. Overlapping data common to both the softtissue dataset and the hard tissue dataset (e.g., data associated withthe dentition) is removed from the hard tissue dataset at step s156. Inanother embodiment, common data is removed from the soft tissue dataset.The region between the resulting merged dataset and the jawbone leaves a“gap,” which corresponds with the thickness of the gingival tissue. Thisgap is then filled in with soft tissue within the model at step s158. Aresulting 3-D anatomic digital model is then obtained at step s160. Asurgical plan may be created from the digital model at step s165. Asurgical guide may be fabricated using the surgical plan at step s166.

The surgical plan may be created using the 3-D anatomic digital modeland planning software. The surgical plan includes information regardingthe location, position, orientation, and size of virtual implants basedon the conditions of the patient's mouth. FIG. 7B illustrates a 3-D CADmodel 161 (on a computer display) of a virtual custom abutment 162 andvirtual implant analogs 163 utilizing the 3-D anatomic digital modelobtained at step s160. An opening 164 in the CAD model 161 is tapered asit leads towards the virtual implant analog 163. This tapering is chosenby the operator of the CAD model 161 after consideration of the locationof the underlying dental implant that has been dictated by the castmodel and the location of the adjacent teeth, if any. Further, thetapering is dictated by the size and shape of the virtual customabutment 162 that has been designed by the operator. Although theopening 164 has been illustrated having a straight-wall taper, theopening 164 may have a curved-wall taper. Further, the opening 164 atits terminal and may be circular, elliptical, or have other non-circularshapes as dictated by the virtual custom abutment 142 and thethree-dimensional “saddle” shape of the gingival tissue between adjacentteeth. This opening 164 may be created by a robot manipulator or analternative robot 358 discussed with reference to FIGS. 10A-D.

The resulting surgical plan may be used to create a master cast, whichmay then be used to fabricate a surgical guide (e.g., surgical guide 390of FIG. 14). The method of forming the master cast according to oneprocess is shown in FIG. 8. At step s200, a flowable cast material ispoured into an impression of the gingival surface. The impression usedin step s200 may be the impression obtained during the process ofacquiring the soft tissue dataset described above (e.g., during steps152 of FIG. 7A). It is contemplated that another or a new impressionmay also be used during step s200. For example, a new impression may beused if an intra-oral scanner was used during step s152 of FIG. 7A toacquire the soft tissue dataset.

Before discussing the remaining steps of FIG. 8, attention will be givento FIGS. 9-10. FIG. 9 illustrates one example of a method for developinga cast model of the patient's mandible. FIGS. 10A-D show schematicrepresentations of a robot manipulator system configured to place animplant analog into the cast model of FIG. 9, according to oneembodiment.

FIG. 9 illustrates the making of a cast model using a dental impression310. In the illustration of FIG. 9, flowable cast material 330 is pouredinto the impression 310, which has a contour that is the negativeimpression of the patient's gingival surface. The cast material 330 mayinclude stone or other suitable material. The cast material 330 is thenallowed to solidify at step s202. It should be noted that the skilledartisan will recognize that there are many ways to make a cast. Forexample, various materials may be used.

Referring also to FIGS. 10A-E, after the cast material 330 hassolidified at step s202, a resulting cast model 350 is mounted on a basestructure (e.g., a male base structure 368). The relative positionand/or coordinates of implant analogs 120 to be placed in the cast model350 may be generated using the coordinate system within a 3-D CAD model.The position of the implant analogs replicate the desired location,position, and orientation of the virtual implants to be placed into thepatient's mouth. This desired location, position, and orientation of thevirtual implants was determined by the surgical plan. A common workstructure (e.g., female work structure 369) associated with the robotmay be used in scanning the cast model 350 and in placing the implantanalogs 120 using a robot manipulator 358. It is contemplated that typesof base structures other than those shown in FIGS. 10A-D may also beused. For example, in some embodiments, the cast model 350 may bemounted on a female base structure and the common base structure may bea male base structure. In other embodiments, the scanner and the robotmanipulator do not share a common base structure.

The male base structure 368 is then attached to the work structure 369,as shown in FIG. 10A, and scanned using the 3Shape Scanner (or othersuitable scanning device) at step s204. In one embodiment, the scannermeasures X, Y, and Z positions of one or more features of the cast model350 relative to the axes on the base structure 368, also referred to asthe base structure origin, thereby acquiring a digitized cast dataset ofthe cast model 350. Thus, when the base structure 368 is in a knownposition with respect to the work structure 369, an exact desiredlocation for an implant analog 120 may be determined. In anotherembodiment, a 3Sphere reference is used to create a common coordinatesystem. In this embodiment, a scanner scans a calibration standard withthree spheres thereon. A robot then probes these three spheres. Usingthe scan and probe data, a common coordinate system is establishedbetween the robot and the scanner.

Referring back to FIG. 8, the digitized cast dataset is then merged withthe previously-obtained 3-D anatomic digital model from which thesurgical plan was created (see FIG. 7A) using a second shape-matchingalgorithm at step s206. The second shape-matching algorithm may be thesame as or different from the shape-matching algorithm used to merge thehard tissue dataset and the soft tissue dataset at step s154 of FIG. 7Ato obtain the 3-D anatomic digital model. The coordinates of the virtualimplant(s) to be inserted into the patient's mouth and, thus, thecoordinates of the corresponding implant analogs 120 relative to thebase structure coordinate system, are then extracted at step s208.

The coordinates of the virtual implants are uploaded to the robotmanipulator 358 at step s210. At step s212, the robot manipulator 358inserts the implant analogs 120 into the cast model 350 (see FIG. 10D)in an installation site corresponding with the location, position, andorientation of the virtual implants. The robot manipulator 358 is ableto accurately place the implant analog 120 in the cast model 350 suchthat the position of the implant analog 120 within the cast model 350 issubstantially identical to the position of the virtual implantdetermined by the surgical plan. Because in the illustrated embodiment,there is a need for eight implants 10, eight implant analogs 120 areinserted into the cast model 350. In one embodiment, the robotmanipulator 358 uses the relative position information to place animplant analog 120 into a securing material, such as an epoxy, locatedon the cast model 350.

FIG. 10A illustrates one example of a simple schematic construction forthe robot 358. The skilled artisan would appreciate that numerous typesof robots are available having various control features, motors, andmanipulating arms and tools. For example, the robot 358 may be an EpsonPS5 six-axis robot with an Epson RC520 controller (Seiko EpsonCorporation, Japan). The robot 358 in FIGS. 10A-D performs variousfunctions related to modifying the cast model 350 and placing the actualimplant analog 120. In particular, as will be described in more detailbelow, the robot 358 modifies the cast model 350 after it has solidifiedto create an actual opening that is substantially similar to the virtualopening 164. The position in which to place the implant analogs isdetermined by the surgical plan. The associated virtual openings arerequired to accommodate the analogs. Further, the robot 358 places animplant analog 120 in substantially the same position and withsubstantially the same orientation as the virtual implant analogs 163 ofFIG. 7B.

The robot 358 includes a base structure 359 that is supported on a tableor other work bench. The base structure 359 typically has one or moremoving arms 360 a,b having a terminal structure 361 for supporting oneor more tool holders 362, 363 that grip and/or manipulate tools or othercomponents. As shown, the base structure 359 includes an arm 360 havingmultiple pivotable sections 360 a and 360 b, and the tool holder 362includes a drill bit 364. The terminal structure 361, the arm 360, thebase structure 359, and/or the tool holders 362, 363 include gears andother common components for transmitting rotational energy to a tool(e.g., the drill bit 364) being held by one of the tool holders 362,363.

The arm 360 (and, thus, the terminal structure 361) may be moved in alldirections relative to the cast model 350 and a pallet 365. The pallet365 includes a specific sequence of tools or other components that areplaced within the pallet 365 prior to the operation of the robot 358. Asshown, the pallet 365 includes an additional drill bit 366 at onelocation and an implant analog holder 367 at a second location.Typically, after the data from the 3-D CAD model 161 of FIG. 7B istransferred to the control system for the robot 358, the operator of therobot 358 will be instructed to provide a certain sequence of tools orother components in the pallet 365 to accommodate the development of theparticular opening and the placement of the particular implant analog120 for the case.

In FIG. 10A, the cast model 350 is directly coupled to a base structure368 that is the same base structure that was used for scanning the castmodel 350 at step s204 of FIG. 8. As such, the base structure 368 isused in both the scanning of the cast model 350 and in the latermodification of the cast model 350 by the robot 358. The base structure368 includes alignment features and magnetic features for precisionmating with corresponding structures on the work structure 369associated with the robot 358. The work structure 369 is at a knownlocation relative to the base structure 359 such that any tool or othercomponent within the tool holders 362, 363 can be accurately positionedrelative to the work structure 369.

To help arrange for the precision location of the tool 364 relative tothe cast model 350, the cast model 350 (and its base structure 368) hasan analog coordinate system, which is labeled as X_(A), Y_(A), Z_(A),for locating the custom abutment, which will ultimately fit on theimplant analog to be located within the opening in the cast model 350.If desired, a custom abutment may be designed with respect to the analogcoordinate system. Further, the robot 358 (and the scanning systempreviously used) has its own base coordinate system, which is labeled asX_(B), Y_(B), Z_(B).

When the data from the 3-D CAD model 161 is transferred to the controlsystem for the robot 358, the data includes at least two types of datasets. A first data set indicates the type of implant analog that will beused in the cast model 350. A second data set indicates the relativelocation of the analog coordinate system to the base coordinate systemso that the creation of the hole in the cast model 350 and the placementof the implant analog is substantially identical to that which has beenvirtually modeled. Optionally, a third data set may define the gingivalmargin of the custom abutment 162 so that a properly sized opening maybe created above the implant analog, allowing the custom abutment to fitproperly within the cast model. This optional third data set may behelpful because the actual custom abutment is larger in diameter thanthe implant analog such that the opening must be contoured in a taperedfashion (e.g., straight-wall taper, curved wall taper, etc.) toaccommodate the actual custom abutment.

The robot 358 of FIG. 10A may also include a calibration mechanism 370such that the tool (e.g., the tip end of drill bit 364) is placed at aknown location and “zeroed” before developing the opening and/orplacement of the implant analog. As shown, the calibration system 370includes two intersecting lasers (e.g., HeNe lasers) 371, 372. Prior toany work on the cast model 350, the tool 364 is placed at theintersection of the two lasers 371, 372 to insure accuracy of the tool364 within the base coordinate system (X_(B), Y_(B), Z_(B)). Theoperator can slightly adjust the tool 364 to place it at theintersection of the two lasers 371, 372, assuming the calibration system370 indicates that an adjustment is needed or if the operator mayvisualize that an adjustment is needed.

In FIG. 10B, the drill bit 364 has been moved by the robot 358 to beginthe development of the opening in the cast model 350. The drill bit 364creates the contoured pocket of the opening (as dictated by the taperedopening 164 in FIG. 7B). The drill bit 364 has a smaller diameter thanany portion of the opening such that it is used as a milling tool tocreate the contoured pocket. In one embodiment, the drill bit 364 thencreates the lower portion of the opening that will receive the implantanalog 120. In doing so, the drill bit 364 of the robot 358 creates abottom wall to the opening that is located at a position within the castmodel 350 that will cause the particular implant analog for that case tohave its upper mating surface (see FIG. 10E) at a location that issubstantially identical to the location of the virtual implant. Inanother embodiment, the hole for the analog (the “analog pocket”) isoversized relative to the analog in all dimensions. The robot 358 thenholds the analog in space within the confines of the analog pocket whilethe adhesive bonds the analog to the cast model 350.

FIG. 10C illustrates the end result of an opening 374 that was createdin the cast model 350 by the robot 358. While the development of theopening 374 has been described by the use of a single drill bit 364, itshould be understood that the robot 358 can utilize multiple tools(e.g., a second drill bit 366 in the pallet 365, or a more traditionalmilling tool) to create the opening 374. Further, because multiplevirtual implants are required in the illustrated embodiment, the robot358 is required to create multiple openings 374, each of which usesmultiple tools from the pallet 365. The use of multiple tools mayrequire a calibration by the calibration system 370 (FIG. 10A) prior tothe use of each tool.

FIG. 10D illustrates the movement of the robot 358 to grip an implantanalog holder 375 from the pallet 365 by use of the tool holder 363 forplacement of the implant analog 120. Once the opening 374 has beencompleted, the operator will remove all remaining particles and debrisfrom the drilling process from the cast model 350. An adhesive is placedwithin the opening 374 and also placed (e.g., manually brushed) on theterminal end of the implant analog 120. Alternatively, an adhesiveactivator agent is placed on the implant analog 120 to accelerate thecuring process. It should be understood, however, that the work stationfor the robot 358 may have bins of adhesive (and activator agents) suchthat the robot 358 “dips” the end of the implant analog 120 into one ormore of these bins without manual operator intervention.

After calibrating the location of the implant analog 120 with thecalibration system 370 (FIG. 10A), the robot 358 then moves the implantanalog holder 375 in such a manner so as to place the implant analog 120at the bottom of the opening 374. In doing so, the orientation of theanti-rotational feature of the implant analog 120 is critical such thatit matches the orientation of the anti-rotational feature of the implantin the patient's mouth (i.e., all six degrees of freedom are constrainedin the same manner as the implant that is located in the patient'smouth). When the robot 358 has finished placement of the implant analog120 within the opening 374, an energy source (e.g., UV light source) isused to quickly cure the adhesive such that the implant analog 120 isphysically constrained and attached to the cast model 350 within theopening 374. Preferably, the adhesive is a UV-curable adhesive.

Once the adhesive has cured, the robot 358 commands the grippingmechanism of the tool holder 363 to release the implant analog holder375. The implant analog holder 375 is held to the implant analog 120through a long screw. Thus, the operator removes the long screw suchthat the implant analog 120 remains by itself within the opening 374(attached via the adhesive), as is shown in FIG. 10E. In particular, theimplant analog 120 and its threaded bore 377 and anti-rotational feature378, are located at a specific position and orientation within theopening 374. It should be understood that the robot 358 may also includethe necessary tools (e.g. screwdriver tip) in the pallet 368 to releasethe implant analog holder 375 from the implant analog 120 so thatoperator intervention is not required.

FIG. 11 illustrates a resulting master cast 400 once multiple implantanalogs have been inserted via the robot 358 of FIGS. 10A-D. The mastercast 400 includes the eight implants analogs 120 that will replicate thepositions of the eight dental implants 10 that will be inserted into thepatient's bone by use of the surgical guide.

Referring back to FIGS. 1-6 as needed, FIG. 12 shows a method of forminga surgical guide from the master cast 400 according to one process. Atstep s450, implant-analog mounts 100 (see FIGS. 13A-13B) are attached tothe master cast 400, and master tubes 20 are attached to implant analogmounts 100. The master tubes 20 are locked onto the implant analogmounts 100 due to the expansion of the top portion of the implant analogmount 100 as the implant analog mount screw is threaded into the implantanalog 120. The implant analog mount screw essentially acts as a wedgewithin the body of the implant analog mount 100, and the top portion ofthe body of the implant analog mount 100 is able to expand because it isslotted. FIGS. 13A-13B illustrate the implant-analog mounts 100 andimplant analogs 120 located within the master cast 400 of FIG. 11. Thetop flange of the expandable top section 104 rests on the master tube 20with the orientation pin 112 fitting within one of the two notches 84 ofthe master tube 20. As such, the location of the non-rotation feature122 of the implant analog 120 is known and fixed relative to the mastercast 400. Once properly seated, the large rotatable head 110 is rotateda bit more (typically less than one-half revolution) to cause theexpandable top section 104 to expand outwardly into the master tube 20and lock itself into axial position.

A polymeric material 390 a such as acrylic (or another suitablematerial) is then poured over the master cast 400 and around mastertubes 20 of FIGS. 13A-13B to form a surgical guide 390 (see FIG. 14) atstep s452. Preferably, the master tubes 20 are placed in the surgicalguide 390 such that their uppermost surfaces are located on flatsurfaces 392 (see also FIG. 14) of the surgical guide 390. Once all ofthe polymeric material 390 a has hardened and cured, the large rotatablehead 110 of the implant-analog mount 100 may be loosened, which unlocksthe implant-analog mount 100 from the master tube 20 and eventuallyreleases the implant analog mount 100 from the implant analog 120 suchthat the resulting surgical guide 390 may be removed from the mastercast 400 and the implant-analog mount 100 may be removed from thesurgical guide 390 at step s454.

The resulting surgical guide 390 fits snugly onto the patient's gingivalsurface by having a negative impression that incorporates the details ofthe gingival surface in the patient's mouth. Because in the illustratedembodiment, there is a need for eight implants 10, the surgical guide390 includes eight openings, each of which is defined by a master tube20 that is integrated into the material of the surgical guide 390 withthe assistance of the outer roughened surface and/or adhesive. Asdescribed above, the end result is that the eight dental implants 10 areinstalled in the patient's maxilla at the depths and angles defined bythe surgical plan, and the eight dental implants 10 may then be attachedto a bar structure that is part of the denture-type dental prosthesisthat is developed for that particular patient. Alternatively, dentalabutments and/or individual prostheses may be attached to the dentalimplants 10.

The under portion of the surgical guide 390 (not visible in FIG. 14) hasa contour that follows the master cast 400 and, thus, the scannedgingival surface in the patient's mouth. In other words, the underportion of the surgical guide 390 is a negative impression of thegingival surface of the patient's mouth.

The surgical guide 390 of FIG. 14 also includes a plurality of openings394 through which temporary fixation screws or pins may be placed. Thetemporary fixation screws or pins engage the bone and hold the surgicalguide 390 in the proper location on the gingival surface so that thesurgical plan may be executed using the surgical guide 390. Aspreviously mentioned, the surgical guide 390 may also be a negativeimpression of the surface of adjacent teeth and bone tissue in somesituations and rest against the adjacent teeth and bone tissue.

As previously indicated, the implant mounts 40 of FIG. 2 are availablein various lengths so that a suitable combination may be identified foreach case. Dimension “E” of FIG. 1B simply needs to be greater than orequal to the height of the master tube 20 plus the distance from theimplant (or analog) seating surface to the highest point on thesurrounding gingival margin.

FIG. 15 illustrates the surgical guide 390 positioned within a patient'smouth. A clinician is generally given a set of instructions, inaccordance with the surgical plan, for placing each dental implant 10with a specific sequence of guide-tube tools and drill bits (along withother components and tools). Each implant is attached to aspecifically-sized implant mount 40 in accordance to the plan. Inparticular, the implant 10 is screwed into the bone by use of a toolthat engages the driving element 48 of the implant mount 40. Because theunderlying non-rotational feature 12 of the implant 10 (FIG. 1) isaligned with the notch 47, the non-rotational feature 12 is oriented inthe exact location defined by the surgical plan by aligning the notch 47of the implant mount 40 with the notch 84 in the master tube 20.

The implants 10 may then be fitted with a temporary prosthesis craftedby the clinician using common abutments. Or, the implants 10 may receivea healing cap or healing abutment to allow for a period ofosseointegration before a temporary or final prosthesis is fitted. Aspreviously discussed, because the implant mount 40 has a known length,the exact depth of the implant 10 within the osteotomy is also known, asdefined by the surgical plan for that patient.

Once all of the implants 10 are installed or after each implant isinstalled, the implant mounts 40 may be released from the dentalimplants 10 by unscrewing each of the screws 49 (FIGS. 2-3).Additionally, the surgical guide 390 may be removed from the patient'smouth by removal of the temporary fixation screws or pins from the holes394 in the surgical guide 390.

Because each of the implants 10 are at known locations and have knownorientations defined by the surgical guide 390 in accordance with thesurgical plan, the patient may be immediately fitted with a prosthesisthat was previously made in accordance to the surgical plan. As anexample, a bar structure may be placed on the implants 10 in thepatient's mouth. Eight attachment regions of the bar would fitaccurately on the dental implants 10 and would be coupled to the dentalimplants 10 through typical dentals screws. A temporary or final denturewould then be snapped on the bar structure such that the patient wouldhave a workable set of prosthetic teeth that are defined by the surgicalplan.

The embodiments and processes of the present invention are also usefulfor developing and installing one or more single-tooth prostheticdevices or one or more multi-tooth prosthetic devices in a patient. Inother words, the surgical guide 390 may be smaller such that it onlycovers a limited portion of the dental arch.

In summary, using a 3-D anatomic model incorporates accurate hard tissuedata and soft tissue data to create a surgical plan and then form amaster cast 400 (from the surgical plan and a scan of the pre-surgicalanatomic cast) having master tubes 20 that allow for the knownorientation of the virtual implants 10 and the implant analogs 120. Asurgical guide 390 may then be accurately developed to replicate thedesired conditions in the patient's mouth in accordance with the 3-Danatomic digital model. The surgical guide 390 may then be fitted to apatient's mouth and the implants 10 may be installed in the patient'smouth in substantially the identical location, position, and orientationas the virtual implants of the surgical plan. The prosthetic device maythen be fitted to the implants 10 that have been installed in thepatient's mouth.

While particular embodiments and applications of the present inventionhave been illustrated and described, it is to be understood that theinvention is not limited to the precise construction and compositionsdisclosed herein and that various modifications, changes, and variationsmay be apparent from the foregoing descriptions without departing fromthe spirit and scope of the invention as defined in the appended claims.

1-8. (canceled)
 9. A method for developing a surgical guide for guidingthe insertion of at least one dental implant into a desired location ina patient's mouth, the method comprising the acts of: obtaining a firstdataset associated with hard tissue of the patient's mouth and a seconddataset associated with soft tissue of the patient's mouth; forming a3-D anatomic digital model including the first dataset and the seconddataset; creating a surgical plan defined by the 3-D anatomic digitalmodel, the surgical plan including virtual implant positions; scanning acast model of the patient's mouth to obtain a third dataset; combiningthe third dataset with the 3-D anatomic digital model; placing at leastone implant analog in the cast material in a location replicating thelocation of the at least one virtual implant in accord with the surgicalplan; attaching at least one implant-analog mount and at least onemaster tube into the cast model in accordance with the surgical plan toform a master cast; pouring a flowable material over the master cast andaround the at least one master tube; allowing the flowable material toharden, the hardened material forming the surgical guide; and removingthe at least one implant-analog mount and the surgical guide from themaster cast.
 10. The method of claim 9, wherein the act of creating thesurgical plan includes using a computed tomography scanner to obtain thedata associated with the hard tissue.
 11. The method of claim 9, whereinthe act of creating the surgical plan includes using an intra-oralscanner to obtain the data associated with the soft tissue.
 12. Themethod of claim 9, wherein the act of creating the surgical planincludes scanning an impression of the patient's mouth to obtain thedata associated with the soft tissue.
 13. The method of claim 12,further comprising forming the cast model by pouring a cast materialinto the impression.
 14. The method of claim 9, wherein the flowablematerial is a polymeric material, and the master tube is made from ametal, the master tube being embedded in the polymeric material.
 15. Themethod of claim 9, wherein the desired location includes both a positionand an orientation of the dental implant.
 16. A method of developing asurgical guide for guiding the insertion of at least one dental implantinto a desired location in a patient's mouth, the method comprising theacts of: scanning the inside of the patient's mouth to obtain a firstdataset associated with bone tissue, teeth, or a combination thereof;taking an impression of the patient's mouth; scanning the impression toobtain a second dataset associated with a gingival surface; merging thefirst dataset with the second dataset to form a 3-D anatomic digitalmodel having gingival thickness data; forming a cast model from theimpression; creating a surgical plan having virtual implants via the 3-Danatomic digital model, the virtual implants having location informationassociated therewith; scanning the cast model to obtain a third dataset;using a robot, placing at least one implant analog in the cast model ata position dictated by the virtual implant location information.
 17. Themethod of claim 16, wherein the act of scanning the inside of thepatient's mouth to obtain a first dataset includes using a computedtomography scanner to obtain the data associated with hard tissue. 18.The method of claim 16, wherein the flowable material is a polymericmaterial and the master tube is made from a metal, the master tube beingembedded in the polymeric material.
 19. The method of claim 16, whereinthe virtual implant location information includes information, whereinthe size information dictates the size of the implant analog.
 20. Themethod of claim 16, wherein the virtual implant location informationincludes orientation information, wherein the orientation informationdictates the orientation of the implant analog
 21. The method of claim16, further comprising, prior to scanning the cast model to obtain athird dataset, mounting the cast model onto a base structure toestablish a coordinate system.
 22. The method of claim 21, furthercomprising, prior to placing at least one implant analog, extractingcoordinates of the desired location of the dental implant relative tothe cast model.
 23. The method of claim 22, wherein the act of placingat least one implant analog is performed by a robot manipulator.
 24. Amethod of developing a 3-D model of the patient's mouth, the methodcomprising the acts of: scanning the inside of the patient's mouth toobtain a first dataset including data associated with the jawbone, bonetissue, teeth, or combinations thereof; scanning the inside of thepatient's mouth or an impression of the patient's mouth to obtain asecond dataset including data associated with the gingival surface;merging the first dataset with the second dataset to form a combineddataset; removing overlapping data from the combined dataset to form amodified dataset; and adding soft tissue data associated with the regionbetween the gingival surface and the jawbone to the combined dataset.25. (canceled)